Internet of things-based management versus standard management of home noninvasive ventilation in COPD patients with hypercapnic chronic respiratory failure: a multicentre randomized controlled non-inferiority trial

Background Effective monitoring and management are crucial during long-term home noninvasive positive ventilation (NPPV) in patients with hypercapnic chronic obstructive pulmonary disease (COPD). This investigated the bene fi t of Internet of Things (IOT)-based management of home NPPV. Methods This multicenter, prospective, parallel -group, randomized controlled non -inferiority trial enrolled requiring long-term home NPPV for hypercapnic COPD. Patients were randomly assigned (1:1), via a computer generated randomization sequence, to standard home management or IOT management based telemonitoring of clinical and ventilator parameters over 12 months. The intervention was unblinded, outcome assessment was blinded to management assignment. The primary outcome was the between comparison of the change in health -related quality of life, based on severe respiratory insuff questionnaire scores with a non -inferiority margin of - 5. This study is registered with Chinese Clinical Registry (No. ChiCTR1800019536). Findings Overall, 148 patients (age: 72.7 +/- 6.8 years; male: 85.8%; forced expiratory volume in 1 s: 0.7 +/- 0.3 66.4 +/- 12.0 mmHg), recruited from 11 Chinese hospitals between January 24, 2019, and June 28, 2021, randomly allocated to the intervention group (n = 73) or the control group (n = 75). At 12 months, the mean respiratory insufficiency questionnaire score was 56.5 in the intervention group and 50.0 in the control (adjusted between -group difference: 6.26 [95% CI, 3.71 - 8.80]; P < 0.001), satisfying the hypothesis of non -inferiority. The 12 -month risk of readmission was 34.3% in intervention group compared with 56.0% in the control adjusted hazard ratio of 0.56 (95% CI, 0.34 - 0.92; P = 0.023). No severe adverse events were reported. Interpretation Among stable patients with hypercapnic COPD, using IOT-based management for home NPPV improved health-related quality of life and prolonged the time to readmission.